Effect of Platelet Inhibition According to Clopidogrel Dose in Patients With Chronic Kidney Disease
- Conditions
- Chronic Kidney DiseaseStable Angina
- Interventions
- Registration Number
- NCT01328470
- Lead Sponsor
- Kyunghee University Medical Center
- Brief Summary
Impaired renal function is associated with reduced responsiveness to clopidogrel. There are no studies which have shown a means by which to overcome platelet hyporesponsiveness in patients with chronic kidney disease (CKD). The purpose of this study was to determine the functional impact of cilostazol in patients with CKD undergoing hemodialysis.
- Detailed Description
The aims of this study is to evaluate the effects of platelet responsiveness to clopidogrel or cilostazol in CKD patients undergoing hemodialysis. The differences in platelet activation markers are also evaluated before and after clopidogrel or cilostazol administration. The investigators will perform a prospective, randomized study to compare the degree of platelet inhibition and platelet activation markers by adjunctive cilostazol (100 mg twice daily) compared to clopidogrel (75 or 150 mg/day) in CKD patients undergoing hemodialysis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease
- known allergies to aspirin, clopidogrel, or cilostazol thienopyridine use before enrollment
- concomitant use of other anti-thrombotic drugs (oral anticoagulants and dipyridamole)
- platelet count <100 x 106/μL
- hematocrit < 25%
- liver disease (bilirubin > 2 mg/dl)
- active bleeding or bleeding diathesis
- gastrointestinal bleeding within the last 6 months
- hemodynamic instability
- acute coronary or cerebrovascular event within 3 months
- malignancy
- concomitant use of a cytochrome P450 inhibitor or a non-steroidal anti-inflammatory drug
- recent treatment (<30 days) with a glycoprotein IIb/IIIa antagonist.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description clopidogrel 75 mg/day Clopidogrel, cilostazol CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 75 mg/day for 14 days. adjunctive cilostazol Clopidogrel, cilostazol CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive co-administration of adjunctive cilostazol (100 mg twice daily) and clopidogrel (75 mg/day; \[group 3, 20 patients\]) for 14 days. clopidogrel 150 mg/day Clopidogrel, cilostazol CKD patients undergoing chronic hemodialysis and PCI for stable coronary artery disease will be randomized to receive clopidogrel 150 mg/day for 14 days. 75mg clopidogrel Clopidogrel, cilostazol control group undergoing PCI for stable angina will be also maintained on clopidogrel (75 mg/day for 14 days).
- Primary Outcome Measures
Name Time Method The differences of platelet aggregation according to the anti-platelet therapy. 14 days Platelet function was assessed with light transmittance aggregometry and the VerifyNowTM P2Y12 assay.
High on-treatment platelet reactivity was defined as 5 μmol/L of ADP-induced Aggmax \> 50%.
Inhibition of platelet aggregation (IPA) was defined as the percent decrease in aggregation values obtained at baseline and after treatment.
VerifyNow-P2Y12 assay results are also assessed and expressed in P2Y12 reaction units (PRUs) and the percentage of inhibition.
- Secondary Outcome Measures
Name Time Method Changes of platelet activation markers according to the anti-platelet therapy 14 days Markers of platelet activation (soluble CD40 ligand \[sCD40L\] and soluble P-selectin \[sP-selectin\]) were assessed at baseline and after 14 days of anti-platelet therapy.
Trial Locations
- Locations (1)
Kyung Hee University
🇰🇷Seoul, Korea, Republic of